The CFDA released on December 1 a draft document, Implementation Rules for Confidentiality Management of Drug Evaluation and Approval Information, for public comments, according to WiCON|Pharma China (www.pharmachinaonline.com), the most trusted English media and business intelligence service covering the Chinese pharmaceutical marketplace, quoting information from the CFDA.
Beijing, China, December 06, 2017 — The CFDA released a draft document, Implementation Rules for Confidentiality Management of Drug Evaluation and Approval Information, on December 1 for public comments, according to WiCON|Pharma China, the most trusted English media and business intelligence service covering the Chinese pharmaceutical marketplace (www.pharmachinaonline.com), quoting information from the CFDA.
Feedback need to be returned via the following means before December 31, 2017: Email: [email protected] Tel: +86 10-68921713
For full text of the document in Chinese, please visit the following CFDA weblink:
WiCON|Pharma China (www.pharmachinaonline.com) prepared an extensive summary of the draft document. The document has a total of 22 articles. It covers relevant personnel and external experts who are involved with drug registration acceptance, technical review and administrative approval.
The following information are considered confidential as provided under the draft document: 1) production processes, key technical parameters, know-how and experimental data submitted by applicants which belong to commercial secrets, technical secrets and personal privacy; 2) drug evaluation related information not approved for public disclosure such as meeting minutes and evaluation discussion summaries/conclusions; 3) complaints and tips from the public related to drug evaluation and approval; and 4) other confidential information deemed by the CFDA.
Full summary of this document in English is available to subscribers of WiCON|Pharma China at www.pharmachinaonline.com. Contact [email protected] for subscription information or join Pharma China weekly e-alert (Basic Edition) for free.
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